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A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

NCT03281304

TerminatedPhase 4

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: CP-690,500 5 mg, CP-690,550 10 mg

Countries: United States, Belgium, Canada, Czechia, France, Germany, Hungary, Italy

This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.
* In stable remission on CP-690,550 10 mg BID
* Agree to use highly effective contraception
* Negative pregnancy test
* Comply with visits, treatments, lab tests, diary and other study procedures
* Signed and dated informed consent document.

Exclusion Criteria:

* Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease
* Likely to require surgery for ulcerative colitis during study
* Expected to receive any prohibited medication
* Expected to receive live or attenuated virus vaccination during study
* Women who are pregnant or breastfeeding or planning to become pregnant during the study
* Evidence of colonic malignancy or any dysplasia
* Acute or chronic medical or psychiatric condition that may increase risk of participation
* Investigator site staff member
* Subjects likely to be uncooperative or unable to comply with study procedures
* Participation in other studies involving investigational drugs during study
* Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:

  * has heart failure;
  * has inherited coagulation disorders;
  * has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
  * is taking combined hormonal contraceptives or hormone replacement therapy;
  * has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
  * is undergoing major surgery
Locations (80)
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • San Diego, California, United States
  • Bristol, Connecticut, United States
  • Bristol, Connecticut, United States
  • Plainville, Connecticut, United States
  • Port Orange, Florida, United States
  • Zephyrhills, Florida, United States
  • Topeka, Kansas, United States
  • Chevy Chase, Maryland, United States
  • Chevy Chase, Maryland, United States
  • Chesterfield, Michigan, United States
  • Macomb, Michigan, United States
  • Troy, Michigan, United States
  • Lake Success, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Mentor, Ohio, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Tyler, Texas, United States
  • Tyler, Texas, United States
  • Salt Lake City, Utah, United States
  • Salt Lake City, Utah, United States
  • Leuven, Belgium
  • London, Ontario, Canada
  • Saskatoon, Saskatchewan, Canada
  • Strakonice, Czechia
  • Nantes, France
  • Pessac, France
  • + 50 more on CT.gov